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Etaphylline

Composition:
Each 100 ml contains:
Acefylline piperazine           2 g
Sodium Phenobarbital        0.066 g

Properties:
Acefylline is a theophylline derivative which is used as a bronchodilator similarly to theophylline.It relaxes smooth muscles, relieves bronchospasm & has a stimulant effect on respiration. It stimulates the myocardium & central nervous system, decreases peripheral resistance & venous pressure & causes diuresis. The mechanism of action is still not clear, inhibition of phosphodiesterase with a resulting increase in intracellular cyclic AMP does occur, but not apparently at concentrations normally used for clinical effect. Other proposed mechanisms of action include adenosine receptor antagonism, prostaglandin antagonism & effects on intracellular calcium. Sodium phenobarbital is a non-selective central nervous system depressant that is primarily used as sedative-hypnotic.

Indications & usage:-
For the relief of:
- Bronchospasm & anxiety or insomnia in asthma, bronchitis & emphysema.

Contraindications:
This product is contraindicated in individuals who have shown hypersensitivity to its components. It is also contraindicated in patients with active peptic ulcer disease & in individuals with underlying seizure disorders (unless receiving appropriate anticonvulsant medication).
Phenobarbital is contraindicated in acute porphyria & in those patients in whom Phenobarbital produces restlessness and/or excitment.

Side effects:
Nausea, vomiting, abdominal pain, diarrhea, gastrointestinal bleeding, headache & palpitations may occur.

Drug interactions:
- Toxic synergism of acefylline with ephedrine & with some other sympathomimetic bronchodilators may occur.
- High dose of allopurinol, ciprofloxacin, clindamycin or oral contraceptives cause increased serum acefylline levels.
- Carbamazepine, phenytoin & rifampicin cause decreased acefylline levels.
Warnings & precautions:
•    Concomitant administration of Etaphylline Phenobarbital syrup with morphine, curare & stilbamidine should be used cautiously in patients with airflow obstruction because they stimulate histamine release & may also suppress respiration leading to respiratory failure.
•    It is advised not to exceed the recommended dose to avoid the occurance of complications in the nervous system especially in patients with impaired renal functions.
•    Etaphylline phenobarbital syrup should be given with caution to patients with hyperthyroidism, hypertension, cardiac arrhythmias, or other cardiovascular disease as these conditions may be exacerbated.

Pregnancy:
There are no adequate & well controlled studies in pregnant women.
Lactation:
A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdosage:
Overdosage may lead to agitation, diuresis, repeated vomiting, consequent dehydration & cardiac arrhythmias.
Treatment of Overdosage: the stomach should be emptied by emesis or lavage. Elimination may be enhanced by repeated oral doses of activated charcoal.

Dosage & administration: 
Adults: 3 to 5 tablespoonfuls daily in divided doses.
Children: 2 to 6 teaspoonfuls daily in divided doses.
Therapeutic category: Bronchodilator.
Legal category: Prescription only medicine.

Package:
Bottle containing 120 ml.

Storage:
Store in a temperature below 30º C, protect from light.

THIS ISA MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.